Glucose Metabolism and Quality of Life in Healthy Women

Glucose Metabolism, Adrenal Function, Cortisol Metabolism, Body Composition Physical Activity, and Quality of Life in Healthy Women

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01995773

Acronym

Healthywomen

Enrollment

Registered

2013-11-27

Start date

2011-12-31

Completion date

2013-06-30

Last updated

2018-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy women, Quality of life, Glucose metabolism, Adrenal reactivity, Physical activity, Body Composition

Brief summary

Polycystic ovary syndrome (PCOS) is a common endocrine disorder in premenopausal women. Women with PCOS often have problems with fertility, unwanted hair growth, and irregular menstrual cycle. PCOS is associated with obesity, changes in glucose metabolism and low quality of life. In the present study, hormonal profile, glucose metabolism, adrenal functon, androgen levels, cortisol metabolism, anflammatory response, ovarian morphology, body composition, pfysical activity and quality of life is studied in 40 healthy women. The results will be compared with results from studies on women with PCOS in order to investigate any differences in these parametres.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* healthy * No medications * regular menstrual cycle * no hair growth problems * BMI 18-35 kg/m2

Exclusion criteria

* medication * diabetes mellitus * signs of PCOS * BMI \< 18 or \> 35

Design outcomes

Primary

Measure	Time frame	Description
Level of androgens	baseline	Level of testosterone and sexual hormone binding globuline in blood samples

Secondary

Measure	Time frame	Description
Body composition	baseline	Body composition measured by full body DXA-scan with estimates on lean body mass and fat mass
Quality of life	Baseline	Quality of life measured by validated questionnaires
Bone density	baseline	Bone density measured by DXA scan of hip and wrist
Glucose tolerance	5 hours	Glucose tolerance measured by 5 hour oral glucose tolerance test with blood glucose measurements for 5 hours after oral intake of 75 g glucose

Other

Measure	Time frame	Description
Ovarian morphology	at baseline	Ovarian morphology described by vaginal ultrasound with measurements of ovarian volumen and description of phollicles.
adrenal activity	1 hour	Adrenal recativity measured by 1 hour ACTH-stimulation test
physical activity	one week	Physical activity measured by accelerometre

Countries

Denmark

Outcome results